FDA Submission for Combination Products How do you determine the correct FDA submission for combination products? What IS a combination product? A In category: FDA Approval LinkedIn Regulatory Quality
FDA Submission Types, Costs and Timeframes – Which is Right for You? Very few days go by without someone asking me to explain the differences between FDA submission types. This most In category: FDA Approval LinkedIn Regulatory Quality
The Biologics License Application Timeline – A Long, Long Road If you think that getting a medical device onto market is a long and tedious process, be glad you don't have to deal In category: Regulatory Quality
Supplier Criticality – What the #@%$ Does That Mean? Customers ask me all the time - "Michelle, I keep hearing this term - supplier criticality. What does that even In category: Regulatory Quality
Choosing the Right Predicate Device: Apples, Oranges, or Something in Between? How do you go about choosing the right predicate device? Say you've developed a new tree-borne fruit and you need to In category: FDA Approval LinkedIn Regulatory Quality
Intended Use or Indications for Use? Can you explain the difference between intended use and indications for use? The terms are NOT interchangeable, but you In category: FDA Approval Regulatory Quality Submissions
Medical Device Regulation and Ye Olde Snake-Oil Salesman Blame the snake-oil salesmen. It's mostly their fault that we ended up with so much medical device regulation in the In category: LinkedIn Regulatory Quality